The pharmaceutical market is highly regulated. Two sets of laws and
regulations play a crucial role in this market. These are

the intellectual property laws and

the laws and regulations about drug registration.

These two sets of laws have different objectives, and are administered by
different government agencies. Intellectual property rights, notably patents
(on which this briefing note will focus, since they have the most profound
implications on access to medicines) are meant to reward innovation by
providing inventors with temporary monopoly rights. Patents, however, confer
negative rights: a patent on a certain pharmaceutical product means that the
patent holder can prevent others from producing or selling that product. But it
does not give the patent holder the right to actually sell that medicine. In
order to be allowed to sell a medicine, it has to be registered by the national
Drug Regulatory Authority.

The drug regulatory system, or registration system, seeks to ensure that
only medicines of assured safety, quality and efficacy are available on the
national market. This is important, since consumers do not normally have
sufficient information and knowledge about a pharmaceutical product to make
their own assessment about its quality, safety and efficacy. In addition,
medicines that are ineffective or of poor quality can be dangerous, both for
the patient and for public health...